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Poster session 22

1624P - Predictive factors for treatment success of second-line Nal-IRI/5-FU/FA in patients with metastatic pancreatic ductal adenocarcinoma (PDAC) (AIO-PAK-0216)

Date

21 Oct 2023

Session

Poster session 22

Topics

Tumour Site

Pancreatic Adenocarcinoma

Presenters

Manfred Lutz

Citation

Annals of Oncology (2023) 34 (suppl_2): S895-S924. 10.1016/S0923-7534(23)01944-0

Authors

M.P. Lutz1, N. Ansorge2, G. Barmashenko3, C. Burkart4, T. Decker5, T.J. Ettrich6, L. Fischer von Weikersthal7, T. Geer8, A. Gerhardt9, S. Hoefling10, L. Jacobasch11, M. Karthaus12, M.P. Koenigsmann13, T. Leidig14, M. Schulte15, N. Schulte16, A. Schwarzer17, G.M. Siegler18, D.T. Waldschmidt19, S. Raeth20

Author affiliations

  • 1 Internal Medicine Department, Caritasklinikum St. Theresia, 66113 - Saarbruecken/DE
  • 2 Innere Medizin, St. Elisabeth-Krankenhaus, Köln/DE
  • 3 Clinical Studies, AIO-Studien-gGmbH, 14057 - Berlin/DE
  • 4 Innere Medizin Ii, Schwarzwald Baar Klinikum Villingen-Schwenning-Surgical Centre, 78050 - Villingen-Schwenningen/DE
  • 5 Onkologie Hamatologie, Onkologie Hamatologie Ravensburg, 88212 - Ravensburg/DE
  • 6 Klinik Für Innere Medizin I, Universitätsklinikum Ulm, 89081 - Ulm/DE
  • 7 Onkologisches Zentrum, Klinikum St. Marien Amberg, 92224 - Amberg/DE
  • 8 Medizinische Klinik Iii, Diakonie-Krankenhaus, 74523 - Schwäbisch Hall/DE
  • 9 Onkologie Hamatologie, Medizinisches Versorgungszentrum für Blut- und Krebserkrankungen, 14467 - Potsdam/DE
  • 10 Scientific Division, CROLLL GmbH, 90449 - Nürnberg/DE
  • 11 Oncology/heamatology Department, Gemeinschaftspraxis Haematologie - Onkologie, 01307 - Dresden/DE
  • 12 Hematology And Oncology Department, Klinikum Neuperlach-Staedtisches Klinikum Muenchen, 81737 - Munich/DE
  • 13 Hämatologie / Onkologie, Onkologisches Ambulanzzentrum OAZ, 30171 - Hannover/DE
  • 14 Scientific Department, CROLLL GmbH, 90449 - Nürnberg/DE
  • 15 Medical Writing, CROLLL GmbH, 90449 - Nürnberg/DE
  • 16 Zentrum Für Geriatrische Onkologie Und Biologie In Der Metropolregion Rhein Neckar (zobel), Universitätsmedizin Mannheim, D-68167 - Mannheim/DE
  • 17 Praxis Für Hämatologie, Onkologie Und Palliativmedizin, Onkopraxis Probstheida, 04289 - Leipzig/DE
  • 18 Medizinische Klinik 5 Abteilung, Klinikum Nuernberg Paracelsus Medical University, 90419 - Nuernberg/DE
  • 19 Klinik Für Gastroenterologie Und Hepatologie, Universitätsklinikum Köln (AöR), 50937 - Köln/DE
  • 20 Monitoring, AIO-Studien-gGmbH, 14057 - Berlin/DE

Resources

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Abstract 1624P

Background

Second line nanoliposomal irinotecan/5-FU/folinic acid (Nal-IRI/5-FU/FA) increases survival of unselected patients (pts) with metastatic PDAC after gemcitabine-based 1st-line therapy. It is not well defined, which parameters are predictive for the efficacy of a 2nd-line treatment.

Methods

In this prospective trial, 151 pts with locally advanced or metastatic PDAC were enrolled for treatment with biweekly Nal-IRI/5-FU/FA (70 mg/m2, 2400 mg/m2, 400 mg/m2) after failure of gemcitabine/nab-paclitaxel. Primary end point was the time to treatment failure of the 2nd-line therapy (TTF2). Secondary endpoints were overall survival (OS) and quality of life. To evaluate the impact of 1st-line treatment, pts was divided into three cohorts: TTF1low, -medium and -high. Comparative analyses were performed for the TTF1low and TTF1high cohorts, and for a comprehensive set of potential predictive factors.

Results

146 (97%) pts have received at least one dose of medication. Median treatment duration of 2nd-line treatment was 3.71 [95% CI: 2.50, 4.11] months, with 28.3% on treatment after 6 m. Analyses of the TTF1 low (≤ 120 d, n=50) and TTF1high (≥ 210 d, n=49) cohorts and predictive factors for TTF2 are summarized in the table.

Table: 1624P

Selected predictive factors for TTF2 and OS

TTF2 months (95% CI) p-value OS months (95% CI) p-value
Baseline
TTF1 high (N=50) 3.22 [1.77, 4.01] 0.790 6.41 [4.76, 9.99] 0.746
low (N=49) 2.83 [2.10, 4.86] 8.08 [4.73, 10.02]
CA19-9 <100 U/ml (N=36) 5.95 [2.10, 7.06] 0.005 9.26 [6.08, 11.89] 0.035
≥100 U/ml (N=104) 2.86 [2.17, 3.91] 6.67 [5.45, 8.08]
Leukocyte level normal (N=111) 4.07 [3.45, 5.06] <0.001 - -
abnormal (N=35) 2.14 [1.28, 2.69] -
Metastases liver (N=106) 2.79 [2.17, 4.01] 0.047 - -
non liver (N=40) 4.40 [2.92, 6.24] -
During treatment
CA 19-9 decrease (response) ≥ 50% (N=32) 6.05 [4.14, 8.94] <0.001 - -
< 50% (N=81) 2.14 [1.84, 2.83] -

Conclusions

Duration, efficacy, or dose of 1st-line treatment did not correlate with the success of 2nd-line therapy. Significant predictive factors are CA19-9 levels and leucocytes, which correlated with TTF2 and OS. During 2nd line treatment CA19-9 response and reduced pain indicate a benefit from treatment.

Clinical trial identification

EudraCT 2016-005147-17.

Editorial acknowledgement

Legal entity responsible for the study

AIO-Studien-gGmbH.

Funding

Servier Deutschland GmbH.

Disclosure

M.P. Lutz: Financial Interests, Personal, Research Funding: Servier. C. Burkart: Financial Interests, Personal, Advisory Board: Boehringer Ingelheim, Amgen, Bayer. T. Decker: Financial Interests, Personal, Advisory Board: Novartis, Iomedico; Financial Interests, Personal, Invited Speaker: Novartis, Lilly. A. Gerhardt: Financial Interests, Personal, Royalties: Janssen; Financial Interests, Personal, Advisory Board: Janssen, Incyte, Novartis, Shire. M.P. Koenigsmann: Financial Interests, Personal, Advisory Board: AbbVie, AstraZeneca, Bristol Myers Squibb, Celgene, Janssen, Gilead, Novartis, Pfizer, Roche; Financial Interests, Advisory Board: Takeda. G.M. Siegler: Financial Interests, Personal, Advisory Board: BMS, Novartis, Roche, MSD, Janssen; Financial Interests, Personal, Invited Speaker: Janssen; Financial Interests, Institutional, Local PI: BMS, MSD, AstraZeneca; Non-Financial Interests, Principal Investigator: BMS, MSD, AIO GmbH, IKFZ, AstraZeneca, GLA; Non-Financial Interests, Member: AIO GmbH, DGHO, EORTC, DKG. D.T. Waldschmidt: Financial Interests, Personal, Other, Travel: AstraZeneca, Bristol Myers Squibb, Eisai, Roche; Financial Interests, Personal, Speaker’s Bureau: AstraZeneca, Bayer, Bristol Myers Squibb, Eisai, Falk, Incyte. All other authors have declared no conflicts of interest.

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